Life Sciences Barcode & RFID Solutions
Life Sciences Automation with Compliance in Mind
Life Sciences companies today are under constant pressure from regulatory bodies to conform to an increasing number of industry standards, while having to reduce costs and improve efficiencies. ValuTrack’s host of barcode, FDA Compliance software, and labeling solutions let you focus on your core competency of discovering and developing medical technologies and products, while we focus on speeding up workflows, meeting compliance regulations and improving your bottom-line.
Validation: Electronic Record & Automated Data Capture Mgmt
Effective validation helps you ensure that a system does what you need it to do, and that it will function correctly, safely and reliably over time.
Companies whose products are regulated by the U.S. Food and Drug Administration (FDA) – must validate the software and data systems used in their engineering, manufacturing or quality processes. This validation requirement arises from any of several regulations, depending on the company’s processes and business area:
- Electronic records and signatures regulation (21 CFR Part 11)
- Medical Device Quality System Regulation (21 CFR Part 820)
- Pharmaceutical Good Manufacturing Practices (21 CFR Part 211)
- Good Clinical Practices (21 CFR Parts 312, 314 and 320 among others)
- Good Laboratory Practices (21 CFR Part 58)
Though these are specific to the FDA – regulated industry, system validation is an excellent tool for ANY organization utilizing a Quality Management System (QMS) and looking to build confidence that its information systems function as needed and as expected.
Software validation is vital to supply chain management, just as much as quality processes for raw materials or subassemblies. If purchased software is part of your product or manufacturing process, your supply chain strategy should include choosing vendors who can provide documentation and professional services to ensure a thorough trouble free validation.
Validating a Purchased Software System Requires:
- Determining that the vendor has followed effective software development and quality processes.
- Establishing that the purchased system works in the final, installed environment and meets its intended use requirements.
ValuTrack offers expert assistance for both phases of your validation. Call us at 866.825.8382 to learn more about how our validation services can help you implement your system smoothly, document your system for effective operation and maintenance, and comply with your regulatory requirements.